ISO 16140-3:2021 食物链微生物学 方法验证 第3部分：在单一实验室中参考方法和已验证的替代方法的验证方案

标准编号：ISO 16140-3:2021

中文名称：食物链微生物学 方法验证 第3部分：在单一实验室中参考方法和已验证的替代方法的验证方案

英文名称：Microbiology of the food chain — Method validation — Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory

发布日期：2021-01

标准范围

本文件规定了在用户实验室实施的参考方法和经验证的替代方法的验证方案。本文件适用于以下情况下微生物分析（检测和/或量化）、确认和分型所用方法的验证:-供人类消费的产品；-用于动物饲养的产品；-食品和饲料生产、处理领域的环境样品；-初级生产阶段的样品。本文件尤其适用于细菌和真菌。有些条款可适用于其他（微生物）有机体或其代谢产物，具体取决于具体情况。第5条和第6条描述了验证定性方法和定量方法的技术协议。第7条描述了验证已验证的替代确认和打字方法的技术协议。非核武器核查协议-附录F中描述了经验证的参考方法。

This document specifies the protocol for the verification of reference methods and validated alternative methods for implementation in the user laboratory.This document is applicable to the verification of methods used for the analysis (detection and/or quantification), confirmation and typing of microorganisms in:— products intended for human consumption;— products intended for animal feeding;— environmental samples in the area of food and feed production, handling;— samples from the primary production stage.This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis.The technical protocols for the verification of validated qualitative methods and validated quantitative methods are described in Clauses 5 and 6. The technical protocol for the verification of validated alternative confirmation and typing methods is described in Clause 7. The protocols for the verification of non-validated reference methods are described in Annex F.

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